The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey, that will evaluate a large number of subjects, will provide important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.

Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.

Secondary Outcome Measures:

The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine progression to disease.

Biospecimen Retention: Samples With DNA

whole blood, serum, PBMCs

Study Start Date:

March 2008

Estimated Study Completion Date:

June 2013

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Hiv-1-infected haart-treated adult subjects

Criteria

Inclusion Criteria:

Diagnosis of HIV-1 infection

To be under successful HAART treatment with plasma viremia <50 copies/ml in the last 6 months prior to initiation of the study, without a history of virologic rebound

Known CD4+ T cells nadir

Age ≥ 18 years old

Signed informed consent

Exclusion Criteria:

Current therapy with immunomodulators or immunosuppressive drugs, or chemotherapy for neoplastic disorders

Concomitant treatment for HBV or HCV infection

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024556